Oral immunotherapy rollout ‘too slow’

The novel allergy approach will hopefully come to three sites in Australia in the next year.

---

Australia is set to follow Canada’s lead in providing oral immunotherapy for food allergy through the public health system.  

OIT will be made available at three sites, hopefully within the next 12 months, according to an announcement made by Professor Kirsten Perrett, director of the National Allergy Centre of Excellence, at the Australasian Society of Clinical Immunology and Allergy annual conference in Sydney this month. 

“Our remit … is to undertake and embed into routine clinical care a clinical trial on food allergy treatment, in at least three states,” she said. 

“I would like it to be much more than that, but we’re really trying to set up a program where we’re collecting data across multiple states embedded in clinical care.” 

Commenting from the audience, Perth paediatric clinical immunologist Associate Professor Richard Loh said the rollout out was “too slow”. He said some parents were taking their children to the US for treatment at a cost of $70,000 to $100,000.  

He was not keen to see the “have nots” waiting for the evidence to come from the three sites, he said. 

The trial faced many constraints, making it difficult to pin down a timeframe for completion, said Professor Perrett. 

“We’d love to roll it out much faster but … who’s going to manage it? Who’s going to pay for it? At the moment, food challenges [are not] paid for under Medicare,” she said. 

“We’re working collectively and many people are working to move this forward. I say we keep fighting and we take it to the government once we have a program that we believe in and that needs to be rolled out, not just in our tertiary centres or private clinics, but through rural and regional Australia to enable access for everyone. That’s the vision.” 

Ms Jody Aiken, senior health management educator with Allergy & Anaphylaxis Australia, a patient and carer charity, said she still had some “hesitation” about OIT and the ongoing care of patients.  

“In the younger age groups, it’s really exciting because of that plasticity of the immune system. But I still have concerns about [the risks for] older children,” she said. 

Canada’s program has greatly influenced Australian developments. Paediatric allergist Professor Edmond Chan, visiting from the British Columbia Children’s Hospital in Vancouver, was involved in publishing the first Canadian OIT guidelines and protocols in 2017. Canadian babies and pre-schoolers can now access OIT, and older children can undergo a period of sublingual immunotherapy before transferring to OIT. 

Like Professor Loh, Professor Chan and his colleagues were seeing patients travel to neighbouring US for treatment and it bothered them. 

“The debate about whether OIT should be offered outside of research may never end,” he said. 

“And patients desire options other than avoidance. Both clinical trial and real-world safety data provide enough data for it to be at least offered as a treatment option. And given limited resources, preschoolers appear to be the lowest hanging fruit for initiating real world implementation.” 

The emphasis in Australia would be on “going early” because of efficacy and safety, said Professor Perrett. Most of the existing guidelines recommend OIT for four years and older, but research showed the “therapeutic window of opportunity” was in younger children, she said.  

The soon-to-be published Australian EarlyNuts study found that 4% of children introduced to peanuts before 12 months of age reported a reaction. 

In the IMPACT peanut allergy trial, 71% cent of kids who started OIT under the age of 12 months reached sustained unresponsiveness after six months of avoidance. That dropped to 35% for two-year-olds, and 19% for those who started at three years.  

“These figures are quite staggering,” said Professor Perrett. “For every month increase in age at the start of OIT, the odds of remission decrease by 7%”. 

And for every tenfold increase in baseline peanut specific IgE, the odds of remission were reduced by 88%, she said.  

“There’s [also] no doubt that OIT at a lower age is safer,” she said, pointing to the seminal PALISADE trial in which 14% of four to 17-year-olds had a treatment-related systematic allergic reaction and 4% a serious reaction, compared to 2% and 0% of one to three-year-olds.  

To address the gaps in the evidence and questions regarding the specifics of establishing a program, the National Allergy Centre of Excellence is undertaking a food allergy treatment living systematic review to keep abreast of rapidly evolving evidence. It will look at immediate and long-term impacts, outcomes, safety, quality of life, mental health, economic burden, immunological changes, protocols and facets affecting program design. 

“If people would like to be involved in those discussions, please reach out because it’s a pretty exciting time,” Professor Perrett told conference delegates. 

“I can feel in the room that there’s a real paradigm shift, a buzz, a change happening. Let’s get started. Let’s build everyone’s confidence. And let’s just roll that out as quickly as we can and go from there.”